Devices and methods useful for sealing bodily openings

Abstract

Among other things, there are disclosed apparatuses and methods for medically sealing an opening in a vessel or wall. For example, in medical applications, a delivery tube is provided for insertion through a sheath into a vessel (e.g. a blood vessel). A dome-shaped seal fixed to a filament, an absorbent and/or compressible buffer, and a locking member are provided in the delivery tube. The delivery tube is configured so that it can be inserted into the vessel through a sheath. Tension is maintained on the filament to hold the seal against the tube or sheath. The sheath is pulled out, which pulls out the tube at the same time, leaving the seal over the opening in the vessel wall. The locking member compresses the buffer against the outside of the vessel and with the filament holds the seal in place against the inside of a vessel.

What is claimed is: 
     
       1. A vascular closure system, comprising:
 a seal having a relaxed configuration with a domed shape, said seal while in said domed shape having a convex exterior surface, an opposite open concave interior surface, and a rim adjacent said convex and concave surfaces, said seal adapted to contact the interior of a vessel at said rim; 
 a flexible filament fixed to said seal, said filament having a plurality of protuberances fixed thereto; 
 a compressible buffer connected to said filament on and being slidable with respect to said filament and said protuberances; 
 a locking member having a central opening, said locking member adapted to slide along said filament and allow said protuberances through said central opening whereafter said protuberances resist travel back through said opening, said locking member slidable along said filament so as to compress said compressible buffer against an external surface of the vessel and separate the locking member from the external surface of the vessel when the system is in a locked condition. 
 
     
     
       2. The system of  claim 1 , further comprising a pusher member having a longitudinal passage, said filament extending through said passage and said pusher member being proximal of said locking member. 
     
     
       3. The system of  claim 1 , further comprising:
 a delivery tube having a body portion with a distal end, a proximal end and a lumen extending between and through said ends, a proximal boss fixed with respect to said body portion and a distal boss slidable along said body portion between a position in which a portion of the distal boss is beyond said distal end of said body portion and a position in engagement with said proximal boss, and wherein said seal is located within said distal boss and outside of said body portion, said filament extends from said seal through said lumen of said body portion, said buffer is within said lumen of said body portion and said locking member is within said lumen of said body portion and between said buffer and said proximal end of said body portion; 
 an external sheath having a proximal opening through which said delivery tube can be inserted, said distal boss of said tube having a portion larger in diameter than said proximal opening of said sheath, wherein insertion of said delivery tube into said sheath results in said sheath contacting said distal boss and holding it stationary as said body portion of said tube slides through said distal boss. 
 
     
     
       4. The system of  claim 3 , wherein said distal boss forms a seal with a portion of said external sheath. 
     
     
       5. The system of  claim 3 , wherein said proximal and distal bosses each have a respective substantially cylindrical distal portion and an outwardly flared proximal portion, wherein a portion of said proximal boss is adapted to enter within said flared proximal portion of said distal boss, so that said proximal boss blocks travel by said distal boss along said body portion beyond said proximal boss. 
     
     
       6. The system of  claim 5 , wherein one of said bosses includes at least one protrusion and the other of said bosses includes at least one complementary indentation, said at least one protrusion and indentation being positioned so that they meet as an indication that said body portion has traveled a predetermined distance through said distal boss. 
     
     
       7. The system of  claim 3 , wherein said buffer has a length substantially greater than its width and surrounding said filament, said buffer being adapted for compression by said locking member to reduce said length and increase said width to a width greater than that of said body of said delivery tube. 
     
     
       8. The system of  claim 7 , wherein said buffer comprises a folded or rolled sheet of extracellular matrix material, with a central passage allowing said buffer to travel along said filament past at least one of said protuberances. 
     
     
       9. The system of  claim 1 , wherein said buffer comprises a ribbon or sheet of extracellular matrix material and said filament is woven or threaded into said buffer. 
     
     
       10. The system of  claim 1 , further comprising a retaining disk adapted to slide along said filament, and wherein said buffer is positioned between said locking member and said retaining disk. 
     
     
       11. The device of  claim 1 , wherein a distal-most one of said protuberances is closest to said seal, and said distal-most protuberance is sufficiently spaced from said rim of said seal to permit the distal-most one of said protuberances to clear a wall of a blood vessel being closed without causing the point at which the filament is fixed to the concave interior surface to contacts an interior surface of the blood vessel being closed. 
     
     
       12. The device of  claim 11 , wherein said distal-most protuberance is between about 3 mm and 15 mm from an end of the filament fixed to said seal. 
     
     
       13. The device of  claim 1 , wherein said seal is adapted to form a cavity between the concave surface of the seal and a blood vessel being closed, and to have a stressed state when said filament is in tension, wherein in the stressed state said seal deforms at least partially to conform to the blood vessel being closed and prevent fluid from flowing around the rim, from a first area outside of the cavity to a second area inside the cavity, and wherein in the stressed state said seal resiliently tends toward the relaxed configuration, thereby urging said rim against the blood vessel. 
     
     
       14. The device of  claim 1 , wherein said locking member has a diameter, and said rim has a diameter, and wherein said locking member diameter is smaller than said rim diameter. 
     
     
       15. The device of  claim 1 , wherein the seal is elastic, and wherein after said locking member compresses said buffer and at least one of said protuberances passes through said locking member, said elastic seal has a flattened configuration, in which at least a portion of the convex exterior surface is substantially planar, and in which said elastic seal applies tension to said flexible filament, biasing said at least one of said protuberances against said locking member, and biasing said rim in the direction of said interior of said vessel. 
     
     
       16. A bodily opening closure device, comprising:
 a seal member having a thin wall of uniform biodegradable material defining a concave interior surface and a continuously curved rim substantially in a plane, adapted to engage an interior wall of a bodily portion around the bodily opening, the seal member being at least partially evertable; 
 a filament fixed to the concave interior surface of said seal member at a point distal to the plane of the rim; 
 a compressible buffer material slidably received on said filament proximal of said seal member, said filament being woven or threaded into said buffer material; 
 a compression member slidably received on said filament proximal of said seal member, the compression member operable to compress the buffer material when slid against the buffer material along said filament. 
 
     
     
       17. The device of  claim 16 , wherein the seal member is in the shape of a dome in a relaxed configuration, the dome deformable under tension applied by said filament to urge substantially the entire rim of the dome against the interior wall of the bodily vessel.